One Day In-Person Seminar (Code – GRCSEM-6240)

One Day Workshop - Excel Spreadsheet Validation-Step by Step Guide to Data Integrity Compliance

David Nettleton

Leader, Author and Teacher for 21 CFR Part 11

May 16, 2019 - 8:30 AM

Los Angeles, CA

Click here to download a Registration FormRegistration Form

Topic Description: 

In this one-day seminar you will learn how to configure Excel applications with the features required for 21 CFR Part 11 thereby helping you to avoid 483s. Using the risk based computer system validation approach you will validate your own Excel application. Use of the validation templates typically saves two thirds of the validation time and costs. This seminar will improve your Excel skills and create a set of validation documents that you can use for subsequent Excel application and other Commercial Off-The-Shelf (COTS) validation projects.

Participants must bring their laptop and an Excel application to validate. To get full benefit of this workshop it is best to come with a colleague so you can be your own project team.

Learning Objectives: 

  • Learn what does and does not need to be validated.
  • Configure spreadsheet applications for Part 11 compliance without programming macros.
  • Learn how to use Excel’s built in 21 CFR Part 11 features for audit trails, security, data verification, and multiple concurrent users.
  • Validate your application using validation templates.
  • Avoid 483s and warning letters.
  • Use risk assessment to reduce testing and improve productivity.
  • Learn how to specify and test your own GxP Excel application.

Who can Attend: 

  • All Excel users
  • IT
  • QA, QC
  • Laboratory staff
  • Managers, Executives

Next Online and Two Day Events: 

Online: 21 CFR Part 11 Data Integrity: How to Validate Software for SaaS/Cloud, EU, GDPR

Online: Excel Spreadsheet Validation-Step by Step Guide to Data Integrity Compliance

May 14 and 15, 2019: 2 Days - Data Integrity: compliance with 21 CFR Part 11, Annex 11, SaaS/Cloud, and EU GDPR

May 16, 2019: One Day Workshop - Excel Spreadsheet Validation-Step by Step Guide to Data Integrity Compliance

Instructor:

David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 270 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory inspections: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.

Projects involve: medical devices, blood bank, clinical trial, corrective action, document control, electronic data capture, Excel spreadsheets, laboratory instruments, laboratory information management (LIMS), manufacturing, enterprise resource planning, toxicology systems, and VMWare.

David Nettleton is also the co-author of:

  • Managing the Documentation Maze – Answers to Questions You Didn’t Even Know to Ask Wiley 2010
  • Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 (Interpharm/CRC 2004)
  • Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance (Davis Horwood International and PDA 2003).
Click here to download a Registration FormRegistration Form

Day One (8:30 AM to 5 PM)

  • Regulations for Electronic Records (0.5hr, 0.5hr)
  • 21 CFR Part 11 - Electronic Records & Signatures (2hr, 2.5hr)
  • Ten-Step Process for Risk-Based Computer System Validation (0.5hr, 3.0hr)
  • Excel Applications - part 1 (1.5hr, 4.5hr)
    • Create a User Requirements document for your application
    • Create a Project Plan document for your application
    • Create a Functional Specifications document for your application
  • How to Conduct a Hazard Analysis/Risk Assessment (0.5hr, 5.0hr)
  • Excel Applications - part 2 (1.5hr, 6.5 hr)
    • Create a Hazard Analysis document for your application
    • Create a Testing Protocol document for your application
  • Main Concepts to Remember (0.5hr, 7hr)

Next Online and Two Day Events: 

Online: 21 CFR Part 11 Data Integrity: How to Validate Software for SaaS/Cloud, EU, GDPR

Online: Excel Spreadsheet Validation-Step by Step Guide to Data Integrity Compliance

March 05 and 06, 2019: 2 Days - Data Integrity: compliance with 21 CFR Part 11, Annex 11, SaaS/Cloud, and EU GDPR

March 07, 2019: One Day Workshop - Excel Spreadsheet Validation-Step by Step Guide to Data Integrity Compliance

 

David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 270 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory inspections: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.

Projects involve: medical devices, blood bank, clinical trial, corrective action, document control, electronic data capture, Excel spreadsheets, laboratory instruments, laboratory information management (LIMS), manufacturing, enterprise resource planning, toxicology systems, and VMWare.

David Nettleton is also the co-author of:

  • Managing the Documentation Maze – Answers to Questions You Didn’t Even Know to Ask Wiley 2010
  • Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 (Interpharm/CRC 2004)
  • Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance (Davis Horwood International and PDA 2003).



Click here to download a Registration FormRegistration Form

 

Location: Los Angeles, California 

Hotel: Soon to be Decided 

 

 

 

 

 

 

Click here to download a Registration FormRegistration Form

 

Seminar Fee Covers

  • AM/ PM Tea or Cofee
  • Lunch
  • Seminar Presentation Materials
  • GRCTS Welcome Bag
  • GRCTS Attendance Certificate

Next Online and Two Day Events: 

Online: 21 CFR Part 11 Data Integrity: How to Validate Software for SaaS/Cloud, EU, GDPR

Online: Excel Spreadsheet Validation-Step by Step Guide to Data Integrity Compliance

March 05 and 06, 2019: 2 Days - Data Integrity: compliance with 21 CFR Part 11, Annex 11, SaaS/Cloud, and EU GDPR

March 07, 2019: One Day Workshop - Excel Spreadsheet Validation-Step by Step Guide to Data Integrity Compliance

 

Available Options

Fee for One Single Participant - One Day

$745

Fee for Two Single Participants - One Day

$1,345

Fee for Three Single Participants - One Day

$2,015

Fee for Four Single Participants - One Day

$2,685

Fee for Five Single Participants - One Day

$3,355

Fee for Eight Single Participants - One Day

$5,365

Fee for Ten Single Participants - One Day

$6,705

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